FDA recall, , Moderate risk
Windstone Medical Packaging AMS Convenience Kit DSAEK Pack
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
Summary by Recall Canary from the FDA notice
What happened
Windstone Medical Packaging, Inc., of Billings, Montana, recalled 3,260 AMS Convenience Kit: DSAEK Pack - RX kits on July 29, 2026, because the kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags that may have blue Break-off-Parts (BOPs) detached from the infusion port during manipulation.
The FDA added the recall to its Enforcement Report on September 10, 2026, and it was in the weekly enforcement report on September 16, 2026. The kits were distributed in California, Georgia and Washington.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the list below, then check the codes the FDA notice also names.
Incomplete list: 40 of 83 lot codes shown.
AMS Convenience Kit
- Lot code
- 241907
- 241223
- 241034
- 240904
- 240705
- 240633
- 240269
- 238361
- 238197
- 238146
- 238085
- 238084
- 238041
- 237957
- 237901
- 237843
- 237663
- 237444
- 237443
- 236863
- 236740
- 236250
- 236249
- 236111
- 235602
- 235601
- 235442
- 235026
- 235025
- 235024
- 235023
- 234889
- 234839
- 234458
- 233931
- 233930
- 233762
- 233328
- 233224
- 231945
From the FDA notice
DSAEK Pack - RX, Part Number AMS12394B
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Georgia, Washington.
- Company
- Windstone Medical Packaging, Inc.Billings, Montana
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99658
- Recall number
- Z-3138-2026
- Quantity recalled
- 3,260 kits
All recalls from Windstone Medical Packaging, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
